In its latest 10-Q filing with the Securities and Exchange Commission, Boston Scientific announced that as of Oct. 31 it has settled 19,000 of 40,000 product liability cases filed against it concerning its transvaginal mesh product.
A total of 17,277 actions are filed in federal MDL 2326 consolidated before US District Judge Joseph R. Goodwin in In RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, Case No. 12-md-2326, D. Mass.). The company said that more than 3,100 cases are pending in Massachusetts state court.
In addition, the company says it has “made substantial progress” in settlement talks underway with plaintiffs’ counsel representing approximately 3,000 additional cases and claims.
All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing,” the company states.
Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.
Plaintiffs allege the company knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.
Litigation is pending against 8 TVM manufacturers:
- Caldera TVM Class Action In California
- Boston Scientific TVM Litigation MDL 2362
- Bard TVM Litigation MDL 2187
- Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
- Neomedic TVM Litigation MDL 2511
- Cook TVM Litigation MDL 2440
- Coloplast TVM Litigation MDL 2387
- American Medical Systems TVM Litigation, MDL 2325
Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device.